TabsDetailsBasic DetailsDate Posted: Monday, November 6, 2017Status: CompleteMedical Product: extended-release (ER) niacin, fenofibrateHealth Outcome(s): gastrointestinal (GI) bleedintracranial hemorrhageischemic strokeDescription: This report investigates major gastrointestinal (GI) bleeding, intracranial hemorrhage, and ischemic stroke events following new use of extended-release niacin and fenofibrates. Read More Deliverables (1)Mini-Sentinel Modular Program Report: Niacin and Fenofibrate UseAdditional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2007 - August 31, 2013Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Individuals 20-99 years of ageData Sources: Mini-Sentinel Distributed Database (MSDD)Related Links: Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel SystemNiacin and Niacin Combination Products, Fenofibrates, and Omega-3 ProductsConcomitant Use of Niacin and Statins and Concomitant Use of Fenofibrates and Statins
